IntellaTip MiFi XP Ablation Catheter Trial (MiFi-CTI)
Primary Purpose
Atrial Flutter
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
IntellaTip MiFi XP Catheter
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Flutter focused on measuring Atrial Flutter, Ablation, Type I Atrial Flutter, Atrial Arrhythmia
Eligibility Criteria
Inclusion Criteria:
- 18 or older
- indicated for ablation for Atrial Flutter
Exclusion Criteria:
- Thrombus
- Recent MI/cardiac revascularization
- Prosthetic Valves
- recent ablation for atrial flutter
- atrial flutter with reversible cause
- Class IV HF
Sites / Locations
- Royal Adelaide Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IntellaTip XP MiFi
Arm Description
Patients with Atrial Flutter will receive ablation treatment with the IntellaTip MiFi XP catheter
Outcomes
Primary Outcome Measures
Acute Procedural Success
The Demonstration of bi-directional isthmus block at the end of the ablation procedure
Secondary Outcome Measures
Complication Rate at procedure
Determine major complications in patients exposed to the device, which occur within 7 days of the procedure
Full Information
NCT ID
NCT01730807
First Posted
November 16, 2012
Last Updated
May 2, 2017
Sponsor
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT01730807
Brief Title
IntellaTip MiFi XP Ablation Catheter Trial
Acronym
MiFi-CTI
Official Title
IntellaTip MiFi XP Ablation Catheters First in Human Use Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A study to assess the performance of a new catheter design for the treatment of Atrial Flutter.
Detailed Description
A prospective, non-blinded, single arm, single center study designed to assess the performance of the IntellaTip MiFi XP Ablation Catheter for the treatment of recurrent or sustained type I atrial Flutter.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Flutter
Keywords
Atrial Flutter, Ablation, Type I Atrial Flutter, Atrial Arrhythmia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IntellaTip XP MiFi
Arm Type
Experimental
Arm Description
Patients with Atrial Flutter will receive ablation treatment with the IntellaTip MiFi XP catheter
Intervention Type
Device
Intervention Name(s)
IntellaTip MiFi XP Catheter
Intervention Description
Temperature controlled ablation catheter
Primary Outcome Measure Information:
Title
Acute Procedural Success
Description
The Demonstration of bi-directional isthmus block at the end of the ablation procedure
Time Frame
one day
Secondary Outcome Measure Information:
Title
Complication Rate at procedure
Description
Determine major complications in patients exposed to the device, which occur within 7 days of the procedure
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 or older
indicated for ablation for Atrial Flutter
Exclusion Criteria:
Thrombus
Recent MI/cardiac revascularization
Prosthetic Valves
recent ablation for atrial flutter
atrial flutter with reversible cause
Class IV HF
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prashanthan Sanders, MD
Organizational Affiliation
Royal Adelaide Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5001
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
IntellaTip MiFi XP Ablation Catheter Trial
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